We have for several years now advised in respect of a broad range of issues relating to Pharmaceuticals including the regulation and importation of medical devices and pharmaceuticals.

We have assisted clients in relation to:

  • regulatory Data Protection matters including advice on the defense of Regulatory Data Protection claims;
  • the Medicines Marketing Authorisations régime in Malta generally and the local process for challenging a Marketing Authorisation;
  • the transposition in Malta of Medical Products Advertising law and applicable Maltese Guidelines for such advertising;
  • the interruption of supply of medicinal products, wholesale distribution and inclusion in the Government Formulary list;
  • Maltese regulations applicable to medical devices;
  • the regulation of remuneration, gifts and honoraria applicable to healthcare professionals;
  • the legal formalities and regulatory implications relevant to the wholesale distribution of pharmaceuticals outside of Malta by entities established in Malta including conditions for establishment and operations;
  • Marketing Authorisations of veterinary products.
  • the importation of and trade in food supplements;
  • trademark registrations.

Our Pharmaceuticals Group further supports client by liaising with the relevant competent authorities including the Medicines Authority and the Malta Competition and Consumer Affairs Authority.